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June 27, 2018

GW Pharmaceuticals Wins FDA Approval of First CBD Drug

On June 25, 2018, GW Pharmaceuticals plc and its U.S. subsidiary, Greenwich Biosciences, made history in the cannabis industry by winning FDA approval of the drug Epidiolex, a cannabidiol (CBD) oral solution for the treatment of seizures associated with two rare forms of childhood-onset epilepsy (Lennox-Gastaut syndrome and Dravet syndrome).[1] Both Lennox-Gastaut syndrome and Dravet syndrome are debilitating forms of epilepsy that have been known to be difficult to treat. Epidiolex is the first FDA-approved drug containing plant-derived CBD, a non-psychoactive cannabinoid naturally produced by cannabis plants.

In approving Epidiolex, the FDA voiced support for further research and studies on medical uses for cannabis through its approval process. According to FDA Commissioner Scott Gottlieb:

Controlled clinical trials testing the safety and efficacy of a drug, along with careful review through the FDA's drug approval process, is the most appropriate way to bring marijuana-derived treatments to patients . . . . We'll continue to support rigorous scientific research on the potential medical uses of marijuana-derived products and work with product developers who are interested in bringing patients safe and effective, high quality products.[2]

However, Commissioner Gottlieb cautioned that the FDA is prepared to take action against illegal CBD-products marketed with unproven medical claims.

FDA approval of Epidiolex may also prompt the Drug Enforcement Administration (DEA) to reschedule CBD from a Schedule I drug under the Controlled Substances Act, which would be another historic event for the cannabis industry. And, in spite of Attorney General Jeff Sessions's continuing war on cannabis, President Trump has indicated support for such a shift.[3]

Rescheduling Epidiolex is necessary for the drug to become available to patients in the U.S. As part of the approval process, the FDA, through the Department of Health and Human Services, makes recommendations to the DEA regarding scheduling based on scientific and medical studies of scheduled substances such as Epidiolex. In turn, the DEA is required to make a scheduling determination. Additionally, in making its determination, the DEA will likely consider the results of clinical and nonclinical studies regarding the abuse potential of CBD that GW Pharmaceuticals conducted as part of its application for Epidiolex. Although the FDA did not indicate whether it provided a favorable scheduling recommendation for Epidiolex, GW Pharmaceuticals stated in its press release that it expects the DEA to reschedule the drug in the next 90 days.

Rescheduling Epidiolex from a Schedule I drug may have implications for GW Pharmaceuticals' intellectual property surrounding the drug as well. First, enforcing cannabis patents in federal district courts remains a grey area in the industry since cannabis is currently classified as a Schedule I drug. By rescheduling Epidiolex, the drug will become legally available by prescription, and GW Pharmaceuticals should be able to enforce the patents covering Epidiolex like any other pharmaceutical patent. In turn, the company may also experience an increase in inter partes review (IPR) proceedings to challenge patents in its portfolio. As we have previously discussed, one of GW Pharmaceutical's patents involving treating partial seizure by administering CBD is already involved in an IPR proceeding.

Additionally, while the USPTO has categorically declined to grant trademarks based on the cannabis plant itself (and derivatives thereof), as well as cannabis goods and services that contribute to federally illegal activity (often referred to as those that "touch the plant"), rescheduling cannabis-based pharmaceuticals like Epidiolex may help eliminate any hurdles faced in obtaining federal trademark protection for such pharmaceuticals. Indeed, unlike Schedule I drugs, scheduled prescription drugs have a legal use in commerce and are therefore routinely granted federal trademark protection. In fact, the USPTO has already granted a trademark for Epidiolex; but note, in doing so the drug was described broadly, without referring to federally prohibited subject matter (e.g., cannabis), and instead referring to, for example, "medicinal herbs" and "medicinal infusions for the treatment of epilepsy."

Either way, right now the approval and tentative rescheduling of Epidiolex is a step in the right direction and could pave the way for other cannabis-based drugs to gain FDA approval and open up new treatment options for patients suffering from a variety of diseases moving forward.